Scientist/Engineer - Tech Transfer - Axelon Services Corporation
New Brunswick, NJ 08903-0191
About the Job
Pay offers: 55$ to 60$/hr.
Job Description: 50% onsite required
Work Schedule: Normal business hours
Position Summary:
The Scientist provides technical support related to one or more Technology Transfer (TT) projects as well as provide support to the Product Champion cluster.
- This position is accountable for working together with the TT Lead to ensure various project aspects are supported from a technical perspective as well as a timeline perspective.
- This position is responsible for supporting the Product Champion group through Data Verification (DV) activities, change control support, improvement projects, etc.
Duties/Responsibilities:
Support TT Lead for one or more projects
- Actively participates in TT meetings, collaborating with cross-functional group.
- Responsible for detailed reviews of project documents such as protocols, reports, risk assessments, and MBRs.
- Provides assistance to sites to review/resolve quality events as needed.
- Collaborate on TT project definition and support chartered projects as needed.
- Identifies TT issues/risks and proposes ideas for issue resolution. Supports issue resolution as needed.
Support Product Champion Cluster
- Support DV of various product TTs and lifecycle projects.
- Support improvement projects for Product Champion group.
- Identify opportunities for improvement and provide ideas to implement.
- Collaborate with Product Champions and work together to learn about different products and implement various improvements.
Reporting Relationship Reports to Product Champion Cluster Lead
Qualifications - Specific Knowledge, Skills, Abilities:
Required:
o Knowledge in Biologics/sterile liquid drug products, aseptic processing
o Experience in Biologics/Vaccine Aseptic Drug Product Manufacturing and/or Technology Transfer
o Ability to serve as a technical expert for Drug Product manufacturing
o Strong critical thinking, technical writing, and verbal communication
o Demonstrated ability to:
Work in a matrix environment and effectively support the decentralized manufacturing function.
Effectively collaborate with other functions
Desired:
o Thorough knowledge of quality systems, Quality by Design, validation principles for product and engineering design and process control fundamentals
- Education/Experience/ Licenses/Certifications:
Required Bachelor s degree in engineering/science-related field with 3-5 years of relevant experience. Time spent in advanced degree program may consider as equivalent experience.
Job Description: 50% onsite required
Work Schedule: Normal business hours
Position Summary:
The Scientist provides technical support related to one or more Technology Transfer (TT) projects as well as provide support to the Product Champion cluster.
- This position is accountable for working together with the TT Lead to ensure various project aspects are supported from a technical perspective as well as a timeline perspective.
- This position is responsible for supporting the Product Champion group through Data Verification (DV) activities, change control support, improvement projects, etc.
Duties/Responsibilities:
Support TT Lead for one or more projects
- Actively participates in TT meetings, collaborating with cross-functional group.
- Responsible for detailed reviews of project documents such as protocols, reports, risk assessments, and MBRs.
- Provides assistance to sites to review/resolve quality events as needed.
- Collaborate on TT project definition and support chartered projects as needed.
- Identifies TT issues/risks and proposes ideas for issue resolution. Supports issue resolution as needed.
Support Product Champion Cluster
- Support DV of various product TTs and lifecycle projects.
- Support improvement projects for Product Champion group.
- Identify opportunities for improvement and provide ideas to implement.
- Collaborate with Product Champions and work together to learn about different products and implement various improvements.
Reporting Relationship Reports to Product Champion Cluster Lead
Qualifications - Specific Knowledge, Skills, Abilities:
Required:
o Knowledge in Biologics/sterile liquid drug products, aseptic processing
o Experience in Biologics/Vaccine Aseptic Drug Product Manufacturing and/or Technology Transfer
o Ability to serve as a technical expert for Drug Product manufacturing
o Strong critical thinking, technical writing, and verbal communication
o Demonstrated ability to:
Work in a matrix environment and effectively support the decentralized manufacturing function.
Effectively collaborate with other functions
Desired:
o Thorough knowledge of quality systems, Quality by Design, validation principles for product and engineering design and process control fundamentals
- Education/Experience/ Licenses/Certifications:
Required Bachelor s degree in engineering/science-related field with 3-5 years of relevant experience. Time spent in advanced degree program may consider as equivalent experience.
Source : Axelon Services Corporation
